Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

University of Sao Paulo

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Acupuncture Sham; Other: Acupuncture Active

Study type: Interventional

Funder types: Other

Identifiers

NCT05523466

1239/2018

Details and patient eligibility

About

The Objective of this study is to evaluate the heart rate variability in individuals with multiple sclerosis during the applicability of Acupuncture, to analyze the behavior of the autonomic nervous system before, during, and after therapy and the changes of the condition.

Full description

A double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, 40 individuals without previous illness will be evaluated, who will constitute the control group and 40 individuals with MS will constitute the experimental group, paired by age and gender. All participants will undertake active or sham acupuncture sessions. Active-Sham group will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation. Meanwhile, Sham-Active group will carry out the opposite protocol, participants will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals diagnosed with Multiple Sclerosis
• Aged over 18 years
• Motor and intellectual capacity to understand the evaluations
• Light and moderate functional classification levels (EDSS scale)
• Who accept to participate in the study through agreement with informed consent form

Exclusion criteria

• Do not understand the evaluations
• Cardiac diseases that impede the assessment of HRV
• Have a cardiac pacemaker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active-Sham group

Experimental group

Description:

will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation.

Treatment:

Other: Acupuncture Sham

Other: Acupuncture Active

Sham-Active group

Experimental group

Description:

will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation.

Treatment:

Other: Acupuncture Sham

Other: Acupuncture Active